Galapagos candidate cachexia drug, GLPG0492, shows good safety and profile suitable for once-daily oral dosing
(Thomson Reuters ONE) -
· Successful completion of first-in-human trial for GLPG0492
· Plans to initiate extended dose and Proof of Concept
studies in 2011
Mechelen, Belgium; 2 December 2010 - Galapagos NV (Euronext: GLPG) announced
today that it has successfully completed the first-in-human trial for GLPG0492,
its candidate drug for cachexia (loss of weight and muscle mass) and potentially
other indications, such as Duchenne muscular dystrophy. The candidate drug
showed good safety in healthy volunteers and a pharmacokinetic (PK) profile
which supports once-daily oral dosing.
In this first-in-human trial, healthy volunteers were given increasing doses of
candidate drug GLPG0492 by oral administration. Safety data were favorable with
no severe adverse events or changes in vital signs and laboratory parameters
reported. Changes in biomarker levels lasting more than 24 hours were
consistent with once-daily oral dosing. Similar positive safety and dosing
results were seen for elderly volunteers. Galapagos plans to conduct a second
Phase I trial in healthy volunteers in the course of 2011 to assess the safety
and tolerability of GLPG0492 over at least 14 consecutive days. Based on this
trial, a Proof of Concept study is scheduled for late 2011.
"We are encouraged by the promising results of this first clinical trial for
GLPG0492," said Piet Wigerinck, Galapagos' SVP Development. "Comparable safety
and PK profiles were seen for younger and elderly volunteers, the latter being
particularly relevant for a therapeutic aimed at improving muscle function."
Details of the first-in-human clinical trial
The primary endpoints of the first-in-human trial were to determine the safety,
tolerability and pharmacokinetics of the candidate drug GLPG0492. The double-
blind, single ascending dose study was conducted in 16 young healthy human
volunteers, with 12 receiving ascending doses of GLPG0492 (ranging 0.5 to 120
mg) and four receiving placebo. Another group of 12 elderly subjects (> 60
years) received three single 100 mg doses once weekly over a three week period,
to compare the PK profile of the oral solution and capsule formulation.
About GLPG0492 and cachexia
GLPG0492 is an orally available small molecule that Galapagos has developed in
its selective androgen receptor modulator (SARM) program. In pre-clinical
studies, GLPG0492 has shown efficacy in the treatment of cachexia, the
involuntary loss of weight and muscle mass which can affect patients with
diseases such as cancer, chronic obstructive pulmonary disease (COPD) and AIDS.
It is estimated that worldwide more than two million people die annually from
the consequences of cancer-related cachexia[1].
Candidate drug GLPG0492 has been shown to improve muscle mass in animal models,
with minimal cardiovascular, prostate, or virility side effects traditionally
seen in androgen therapies. Galapagos aims for once-a-day oral dosing that
improves muscle mass and function, with minimal effects on hormonal status in
patients. With the support of two foundations - Charley's Fund and the Nash
Avery Foundation - Galapagos is currently evaluating the potential effectiveness
of GLPG0492 in pre-clinical models of Duchenne muscular dystrophy.
Galapagos aims to complete the Proof of Concept study for GLPG0492 in the course
of 2011 before out-licensing the program.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company
specialized in the discovery and development of small molecule and antibody
therapies with novel modes-of-action. The Company is progressing one of the
largest pipelines in biotech, with six clinical and over 50 small molecule
discovery/pre-clinical programs. Through risk/reward-sharing alliances with
GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Merck & Co., Roche and Servier,
Galapagos is eligible to receive up to ?3.3 billion in downstream milestones,
plus royalties. The Galapagos Group has over 800 employees and operates
facilities in seven countries, with global headquarters in Mechelen, Belgium.
More info at: www.glpg.com
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)glpg.com
This release may contain forward-looking statements, including, without
limitation, statements containing the words "believes," "anticipates,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will," "could,"
"stands to," and "continues," as well as similar expressions. Such forward-
looking statements may involve known and unknown risks, uncertainties and other
factors which might cause the actual results, financial condition, performance
or achievements of Galapagos, or industry results, to be materially different
from any historic or future results, financial conditions, performance or
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these uncertainties, the reader is advised not to place any undue reliance on
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of the date of publication of this document. Galapagos expressly disclaims any
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events, conditions or circumstances on which any such statement is based, unless
required by law or regulation.
--------------------------------------------------------------------------------
[1] Muscaritoli et al, Asia Pac J Clin Nutr 2008;17 (S1):387-390
[HUG#1467832]
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Datum: 02.12.2010 - 07:30 Uhr
Sprache: Deutsch
News-ID 49320
Anzahl Zeichen: 6995
contact information:
Town:
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Kategorie:
Business News
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